IVD - CE Marking

IVD - CE Marking

What is In Vitro diagnostic Medical devices?

In vitro diagnostic medical device (IVD) means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:

- Concerning a physiological or pathological state, or

- Concerning a congenital abnormality, or

- To determine the safety and compatibility with potential recipients, or

- To monitor therapeutic measures.

Specimen receptacles are considered to be In Vitro Diagnostic Devices (IVD). ‘Specimen receptacles’ are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination.

Products for general laboratory use are not In Vitro Diagnostic Devices (IVD) unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination

CE Certification or CE Marking under the In vitro diagnostic devices directive (98/79/EC) or in vitro diagnostic devices regulation (IVDR 2017/746) for your in vitro diagnostic devices (IVD)

Selling your In Vitro Diagnostic Devices (IVD) in Europe mandates CE marking on the In Vitro Diagnostic Devices (IVD). CE Marking indicates that an in vitro diagnostic device (IVD) complies with the European In Vitro Diagnostic Devices Directive (98/79/EC). Europe's new In Vitro Diagnostic Regulation (IVDR 2017/746) will come into force in 2022, ushering in substantial alterations to the regulatory necessities for in vitro diagnostic device (IVD).

The CE certification process for in vitro diagnostic device (IVD) is similar to that of medical devices, but there are some key differences.            

The process flow of CE certification of your In Vitro Diagnostic Devices (IVD) under In Vitro Diagnostic Devices Directive (98/79/EC) or new In Vitro Diagnostic Regulation (IVDR 2017/746) is enlisted below:

1.Determination of classification:

Under the in vitro diagnostic devices directive (98/79/EC), the in vitro diagnostic devices (IVD) are classified as

  • List A (Annex II)
  • List B (Annex II)
  • Self-Testing IVDs
  • General in vitro diagnostic medical devices (IVD) (Self certified)

 

Under the in vitro diagnostic device regulation (IVDR 2017/746), the in vitro diagnostic medical devices (IVD) are classified as

  • Class A
  • Class B
  • Class C
  • Class D

 

2.Establishing Compliant Quality Management System:

Under the in vitro diagnostic devices (IVD) directive (98/79/EC) 

  • The self-certified in in vitro diagnostic device (IVD) shall implement Quality Management System (QMS) in accordance with Annex III.
  • For all other in vitro diagnostic device (IVD) classes, implement Quality Management System (QMS) in accordance with Annex IV or VII of 98/79/EC. ISO 13485 can be applied as a mean to comply with these requirements.

 

Under the in vitro diagnostic device regulation (IVDR 2017/746)

  • Class A (non-sterile), you must implement a Quality Management System (QMS) though Notified Body intervention is not required.
  • For all other devices implement a Quality Management System (QMS) in accordance with the in vitro diagnostic regulation (IVDR 2017/746). ISO 13485 can be applied as a mean to comply with these requirements.

 

3.Technical File Preparation:

Technical File shall be prepared for all in vitro diagnostic device (IVD) irrespective of its classification with detailed information on the performance and safety of the in vitro diagnostic device (IVD) and demonstrates compliance with the Essential Requirements of Annex I of the IVDD 98/79/EC and Annex I General Safety and Performance Requirements of the IVDR 2017/746.

4.Appointing Authorized Representative:

An authorized representative shall be appointed for in vitro diagnostic device (IVD) manufacturers located outside the Europe. The EC REP must be located in Europe and competent to handle all regulatory issues as required by In Vitro Diagnostic Devices Directive (98/79/EC) or new In Vitro Diagnostic Regulation (IVDR 2017/746). Place your EC REP name and address on device label. Under the in vitro diagnostic device regulation (IVDR 2017/746). obtain a Single Registration Number from the regulators.

5.Assessment, Audit and Certification:

General in vitro diagnostic device (IVD) are self-certified and do not require Audit by a Notified Body, hence the manufacturers can self-affix the CE Mark on their device.

For all other classes of in vitro diagnostic device (IVD), the Quality Management System (QMS) and the technical documentation shall be audited by an Authorized European Notifying body. Upon successful completion of the Audit, the CE certificate for in vitro diagnostic device shall be issued along with compliance to ISO 13485 for your facility.

Under the in vitro diagnostic device regulation (IVDR 2017/746). all devices except Class A (non-sterile), Quality Management System (QMS) and Technical File or Design Dossier must be audited by a Notified Body, a third party accredited by European authorities to audit medical device companies and products. For all devices except Class A (non-sterile), a European CE Certificate will be issued for the in vitro diagnostic device and an ISO 13485 certificate for the facility following successful completion of Notified Body audit.

6.Declaration of Conformity:

For all classes, prepare a Declaration of Conformity, a legally binding document prepared by the manufacturer stating that the in vitro diagnostic device (IVD) is in compliance with the applicable In Vitro Diagnostic Devices Directive (98/79/EC) or new In Vitro Diagnostic Regulation (IVDR 2017/746). You may now affix CE Marking to in vitro diagnostic device (IVD).

7.Registration of the device:

Some EU member states require additional registration of devices placed on their markets, so In vitro diagnostic device (IVD) must be registered with the European Competent Authority (Ministry of Health) where your Authorized Representative is based. Additionally under the in vitro diagnostic medical device regulation (IVDR 2017/746), the device Unique Device Identifier (UDI) must be registered in the EUDAMED database. UDI must be on label and associated with the regulatory documents

8.Maintaining your CE certification:

Self-certified in vitro diagnostic device (IVD) are not audited yearly and shall continue CE marking their devices as long as they are in compliance with 98/79/EC.

For all other classes, the Notifying body shall conduct yearly audit to ensure compliance to 98/79/EC as per applied Conformity assessment route. Failure to comply with the same may result in suspension of the certificate.

Under the in vitro diagnostic device regulation (IVDR 2017/746), For Class A (non-sterile), annual Notified Body audits are not required. However, Performance Evaluation Report, Technical File, and Post market Surveillance (PMS) activities must be kept on-going and updated.

For all other classes, annual audits will be conducted by a Notified Body to ensure ongoing compliance with the in vitro diagnostic medical device regulations (IVDR 2017/746). Failure to pass the audit will invalidate the CE certificate.

Maven has a team of experts well versed with the Regulatory requirements and vast industrial experience in Research and development, Quality Control, Quality assurance and Regulatory affairs of in vitro diagnostic device (IVD). We provide the following services for your in vitro diagnostic device (IVD):

  • Preparation of Technical files complying with the requirements for CE certification.
  • Quality Management System (QMS) preparation and implementation
  • Preparation of technical documents to comply with In Vitro Diagnostic Devices Directive (98/79/EC) or in vitro diagnostic medical device regulations (IVDR 2017/746).
  • Selection and Appointment of Authorized Representative.
  • Assist in testing needs as required by In Vitro Diagnostic Devices Directive (98/79/EC) or in vitro diagnostic medical device regulations (IVDR 2017/746).
  • Helping in the selection of notified body for the CE Certification.
  • Quality Management System (QMS) Certification by Certification Body.
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